Didamol

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Didamol uses


DESCRIPTION

PERSANTINE® (dipyridamole USP) is a platelet inhibitor chemically described as 2,2',2",2"'-[(4,8- Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:

Didamol is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water.

Didamol tablets for oral administration contain:

Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg : Didamol USP 25 mg, 50 mg and 75 mg, respectively.

Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg : acacia, carnauba wax, corn starch, edible white ink, lactose monohydrate, magnesium stearate, D&C yellow #10 aluminum lake, D&C red #30, helendon aluminum pink lake, sodium benzoate, methylparaben, propylparaben, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and white wax.

Didamol structure

CLINICAL PHARMACOLOGY

It is believed that platelet reactivity and interaction with prosthetic cardiac valve surfaces, resulting in abnormally shortened platelet survival time, is a significant factor in thromboembolic complications occurring in connection with prosthetic heart valve replacement.

Didamol tablets have been found to lengthen abnormally shortened platelet survival time in a dose-dependent manner.

In three randomized controlled clinical trials involving 854 patients who had undergone surgical placement of a prosthetic heart valve, Didamol tablets, in combination with warfarin, decreased the incidence of postoperative thromboembolic events by 62 to 91% compared to warfarin treatment alone. The incidence of thromboembolic events in patients receiving the combination of Didamol tablets and warfarin ranged from 1.2 to 1.8%. In three additional studies involving 392 patients taking Didamol tablets and coumarin-like anticoagulants, the incidence of thromboembolic events ranged from 2.3 to 6.9%.

In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the Persantine® tablets were begun between 24 hours and 10 days postoperatively. The length of follow-up in these trials varied from 1 to 2 years.

Didamol tablets do not influence prothrombin time or activity measurements when administered with warfarin.

Mechanism of Action

Didamol inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5–1.9 μg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A2-receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP).

Didamol inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of Didamol inhibit cyclic-3',5'-guanosine monophosphate-PDE (cGMP-PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide).

Hemodynamics

In dogs intraduodenal doses of Didamol of 0.5 to 4.0 mg/kg produced dose-related decreases in systemic and coronary vascular resistance leading to decreases in systemic blood pressure and increases in coronary blood flow. Onset of action was in about 24 minutes and effects persisted for about 3 hours.

Similar effects were observed following IV PERSANTINE® in doses ranging from 0.025 to 2.0 mg/kg.

In man the same qualitative hemodynamic effects have been observed. However, acute intravenous administration of Didamol may worsen regional myocardial perfusion distal to partial occlusion of coronary arteries.

Pharmacokinetics and Metabolism

Following an oral dose of Didamol tablets, the average time to peak concentration is about 75 minutes. The decline in plasma concentration following a dose of Didamol tablets fits a two-compartment model. The alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. The beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. Didamol is highly bound to plasma proteins. It is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile.

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INDICATIONS AND USAGE

Didamol tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

CONTRAINDICATIONS

Hypersensitivity to Didamol and any of the other components.

PRECAUTIONS

General

Coronary Artery Disease: Didamol has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease. Chest pain maybe aggravated in patients with underlying coronary artery disease who are receiving Didamol.

Hepatic Insufficiency: Elevations of hepatic enzymes and hepatic failure have been reported in association with Didamol administration.

Hypotension: Didamol should be used with caution in patients with hypotension since it can produce peripheral vasodilation.

Laboratory Tests

Didamol has been associated with elevated hepatic enzymes.

Drug Interactions

No pharmacokinetic drug-drug interaction studies were conducted with Didamol® tablets. The following information was obtained from the literature.

Adenosine: Didamol has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary.

Cholinesterase Inhibitors: Didamol may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies in which Didamol was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis. The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m2 basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of Didamol with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when Didamol was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m2 basis).

Pregnancy

Reproduction studies have been performed in mice, rabbits and rats at oral Didamol doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 ½, 2 and 25 times the maximum recommended daily human oraldose, respectively, on a mg/m2 basis) and have revealed no evidence of harm to the fetus due to Didamol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Didamol tablets should be used during pregnancy only if clearly needed.

As Didamol is excreted in human milk, caution should be exercised when Didamol tablets are administered to a nursing woman.

Safety and effectiveness in the pediatric population below the age of 12 years have not been established.

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Didamol tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing Didamol tablets and warfarin therapy to either warfarin alone or warfarin and placebo:

Adverse Reaction Didamol

Tablets / Warfarin

Placebo / Warfarin
Number of patients 147 170
Dizziness 13.6% 8.2%
Abdominal distress 6.1% 3.5%
Headache 2.3% 0.0%
Rash 2.3% 1.1%

Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.

When Persantine® (dipyridamole USP) tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed.

In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.

In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential. Based upon the known hemodynamic effects of Didamol, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. A drop in blood pressure and tachycardia might also be observed.

Symptomatic treatment is recommended, possibly including a vasopressor drug. Gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of Didamol overdose. Since Didamol is highly protein bound, dialysis is not likely to be of benefit.

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75-100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

Didamol tablets are available as round, orange, sugar-coated tablets of 25 mg, 50 mg and 75 mg coded BI/17, BI/18 and BI/19, respectively.

They are available in bottles of 100 tablets as indicated below:

25 mg Tablets (NDC 0597-0017-01)

50 mg Tablets (NDC 0597-0018-01)

75 mg Tablets (NDC 0597-0019-01)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Keep out of reach of children.

Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Licensed from:

Boehringer Ingelheim

International GmbH

Manufactured by:

Boehringer Ingelheim Promeco, S.A. de C.V.,

Mexico City, Mexico

©Copyright Boehringer Ingelheim International GmbH 2006, ALL RIGHTS RESERVED

Printed in the USA

OT1500A

340067/US/7

Revised: June 20, 2006



Didamol (dipyridamole usp) Tablets

NDC:0597-0017-01

Didamol (dipyridamole usp) Tablets

NDC:0597-0018-01

Didamol (dipyridamole usp) Tablets

NDC:0597-0019-01

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Didamol pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Didamol available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Didamol destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Didamol Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Didamol pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PERSANTINE (DIPYRIDAMOLE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DIPYRIDAMOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "dipyridamole". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Didamol?

Depending on the reaction of the Didamol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Didamol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Didamol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Didamol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Didamol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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